The Medicines for Human Use (Miscellaneous Amendments) (No.2) Regulations 2009

• Citation: S.I. 2009/3063
• Sections: 3

Section 1 Citation, commencement and interpretation

(1) These Regulations may be cited as the Medicines for Human Use (Miscellaneous Amendments) (No.2) Regulations 2009 and shall come into force on 21st December 2009.

(2) In these Regulations—

“the Marketing Authorisations Regulations ” means the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 ;

“the Sale or Supply Regulations ” means the Medicines (Sale or Supply) (Miscellaneous Provisions) Regulations 1980 .

Section 2 Amendment of Schedule 1 to the Marketing Authorisations Regulations

(1) Schedule 1 to the Marketing Authorisations Regulations (exemptions and exceptions from the provisions of regulation 3) shall be amended as follows.

(2) In paragraphs 1 and 2(a) and (c) for “or supplementary prescriber” substitute “, supplementary prescriber, nurse independent prescriber or pharmacist independent prescriber”.

(3) At the end of paragraph 1 add—

In this paragraph and in paragraph 2—

“nurse independent prescriber” means a person (“N”)—

who is a registered nurse or a registered midwife, and

against whose name is recorded in the professional register an annotation signifying that N is qualified to order drugs, medicines and appliances as a nurse independent prescriber or a nurse independent/supplementary prescriber;

“pharmacist independent prescriber” means a person (“P”)—

who is a pharmacist, and

against whose name is recorded in the relevant register an annotation signifying that P is qualified to order drugs, medicines and appliances as a pharmacist independent prescriber.

Section 3 Amendment of the Sale or Supply Regulations

(1) The Sale or Supply Regulations shall be amended as follows.

(2) In regulation 1(2) (citation, commencement and interpretation), after the definition of “community practitioner nurse prescriber” insert—

“contact lens specialist” means a person who is a registered dispensing optician and against whose name particulars of the contact lens speciality have been entered in the register of dispensing opticians maintained under section 7(b) of the Opticians Act 1989 ;

“registered dispensing optician” means a person registered in the register of dispensing opticians maintained under section 7(b) of the Opticians Act 1989;

(3) In regulation 5 (restrictions on persons to be supplied with certain medicinal products) at the end insert—

(g) to a registered dispensing optician (“D”), prescription only medicines which—

(i) are required for use by registered optometrists and doctors attending D’s practice but only if the medicine contains any one or more of the following substances—

Amethocaine hydrochloride,

Chloramphenicol,

Cyclopentolate hydrochloride,

Fusidic acid,

Lignocaine hydrochloride,

Oxybuprocaine hydrochloride,

Proxymetacaine hydrochloride,

Tropicamide;

(ii) are required for use by D in the course of D’s professional practice as a contact lens specialist but only if the medicine contains any one or more of the following substances—

Lignocaine hydrochloride,

Oxybuprocaine hydrochloride,

Proxymetacaine hydrochloride.